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FDA Advisory Committee Recommends Approval of Forest Laboratories’ Ceftaroline Fosami

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Medimmune Receives Complete Response Letter On Motavizumab

AstraZeneca today announced that MedImmune, its biologics unit, has received a second complete response letter (CRL) on motavizumab from the U.S. Food and…
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pSivida Announces Iluvien Receives FDA Priority Review for Treatment of Diabetic Macu

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Update on the FDA review for Abstral

Uppsala, September 7, 2010 – Orexo Anrufbeantworter (STO: ORX) announces that the US Food and Drug Administration ("FDA") has informed Orexo’s partner, ProStrakan…
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Pfizer Receives Refusal To File Letter From U.S. FDA On Tafamidis New Drug Applicatio

NEW YORK–(BUSINESS WIRE)–Apr 4, 2011 – Pfizer Inc. (NYSE: PFE) announced today that it has received a Refusal to File letter from the…
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FDA Assigns PDUFA Date for Shire’s Firazyr (icatibant) for the Treatment of Acute Att

DUBLIN and LEXINGTON, Massachusetts, March 21, 2011/PRNewswire-FirstCall/ — Shire plc, the irdisch specialty biopharmaceutical company, today announced that the US Food and Drug…
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Lilly and Avid Receive Complete Response Letter from FDA for Amyvid (florbetapir F 18

INDIANAPOLIS and PHILADELPHIA, March 18, 2011 /PRNewswire/ — Eli Lilly and Company and its wholly owned subsidiary, Avid Radiopharmaceuticals, Inc., have received a…
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FDA Advisory Committee Recommends US Approval of Novartis Once-Daily Bronchodilator Q

Basel, March 9, 2011 – An advisory committee recommended todaythat the Food and Drug Administration (FDA) approve QAB149(indacaterol) in the US as the…
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Merck Announces FDA Acceptance of New Drug Application for Investigational Ophthalmic

WHITEHOUSE STATION, N.J.–(BUSINESS WIRE)–Mar 9, 2011 – Merck, known as MSD outside the United States and Canada,announced today that the New Drug Application…
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Santarus and Pharming Announce Receipt of FDA Refusal to File Letter for Rhucin Biolo

SAN DIEGO & LEIDEN, Netherlands–(BUSINESS WIRE)–Feb 28, 2011 – Specialty biopharmaceutical company Santarus, Inc. and biotech company Pharming Group NV today announced the…
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FDA Accepts New Drug Application for Investigational Compound Dapagliflozin for the T

PRINCETON, N.J. & LONDON–(BUSINESS WIRE)–Mar 8, 2011 – Bristol-Myers Squibb Company and AstraZeneca today announced that the U.S. Food and Drug oeffentliche Hand…
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Seattle Genetics Submits BLA to FDA for Brentuximab Vedotin in Relapsed or Refractory

BOTHELL, Wash.–(BUSINESS WIRE)–Feb 28, 2011 – Seattle Genetics, Inc. announced today that it has submitted a Biologics License Application (BLA) to the U.S.…
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Shire Files Complete Response to FDA’s Not Approvable Letter for Firazyr (icatibant)

DUBLIN, Ireland and LEXINGTON, Massachusetts, February 28, 2011/PRNewswire-FirstCall/ — Shire plc, the irdisch specialty biopharmaceutical company, today announced that it has submitted a…
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Merck Receives Complete Response Letter From FDA on Cladribine Tablets New Drug Appli

DARMSTADT, Germany, March 2, 2011 ? Merck Kommanditgesellschaft auf Aktien announced today that it received a complete response letter from the FDA on…
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FDA Accepts Lundbeck Inc. Submission of New Drug Application for Clobazam

DEERFIELD, Ill.–(BUSINESS WIRE)–Mar 4, 2011 – Lundbeck Inc. today announced the U.S. Food and Drug Administration (FDA) has accepted for review a New…
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